Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers

Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers - Clinical trila by chemotherapy-combined peptide vaccination for metastatic biliary tract cancers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004494

Enrollment

Registered

2010-11-03

Start date

2010-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic biliary tract cancers

Interventions

emcitabine+CDDP/vaccination (first line), S-1/vaccination (second line). genetic type of HLA-A is blinded and will be key-open at the end of trial.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically diagnosed biliary tract cancers -bile duct cancer, gall bladder cancer or ampulla cancer of duodenum. 2. Primary tumor is not curatively resectable or metastatic lesion is not curatively resectable. 3. Patient, obtains measurable lesions. 4. Patient, has no previous treatments other than surgery. Previous treatments include artery-infusional chemotherapy and postoperative adjuvant chemotherapy. 5. older than 19 years. 6. PS=0, 1 or 2 (ECOG). 7. Oral intake is possible. 8. Major organ functions, such as bone marrow, heart, liver, kidney, are obtained, as follows (data within 14 days before trial registration) WBC>=3500/microL and <=10000/microL platelets>=100000/microL lymphocytes>=1000/microL GOT(AST)<=100IU/L GPT(ALT)<=100IU/L T-Bilirubin<=2.0mg/dL (<=3.0mg/dL cases with biliary drainage) creatinine<=1.2mg/dL CCR>=50mi/min (Cockcroft-Gault) 9. Patients expected to live more than three months 10. Documented informed consent

Exclusion criteria

Exclusion criteria: Patients -obtains previous radiation therapy for biliary tract cancers. -obtains brain metastasis not manipulated. -obtains active duplicated neoplastic diseases. -obtains co-morbidity as follows; intestinal paralysis, intestinal obstruction, diabetes mellitus, hypertension, angina pectoris, livet cirrhosis, pneumonitis, emphysema. -is HIV-positiveness -has past history of severe allergic reaction for gemcitabine, cisplatin, or TS-1. -obtains ascites or pleural effusion that needs treatment. -has severe diarrhea or GI bleeding. -has treatment by frucitosine -is pregnat or can be pregnant. -desires partners pregnancy. -has HLA-A genotype opened.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
DCR, RR, PFS, AE, immunological reactions (CTL, CD8, regT)	—

Countries

Japan

Contacts

Public ContactTakahiro Mori, MD PhD

Tohoku University Graduate School of Medicine Tohoku University Cancer Center

tamori@med.tohoku.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026